Bard® DigniShield® Stool Management System


Product Overview

Bard® DigniShield® Stool Management System
Bard® DigniShield® Stool Management System - SMS002


Device Description

A collection of devices used for the conveyance and collection of liquid/semi-liquid stool (faeces) from the rectum to a collection bag for a patient who is unable to control stool discharge. It typically includes a balloon catheter, a disposable collection bag, a syringe, connectors, and ports for balloon inflation and irrigation. The catheter is inserted into the rectum where it is retained by the inflatable balloon for a prescribed length of time. The kit is appropriate for adult patients in an intensive care unit (ICU), other acute care settings, or for persons with a disability. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 127.00
    • N/A

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: KNT

    Device Name: Tubes, Gastrointestinal (And Accessories)

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: GU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 876.5980

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 10801741045940

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00801741045943

    Package Quantity: 2

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CA


    Device Id: 00801741045943

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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